Helius Medical to submit additional data to FDA for its portable neuromodulation device

Helius Medical Technologies Inc (NASDAQ:HSDT) disclosed Friday that the Food and Drug Administration wanted additional information related to its 510(k) application under the De Novo pathway for its Portable Neuromodulation Stimulator (PoNS) device.

Helius stock tumbled nearly 10.6% lower to $6.81 in pre-market, but the neurotech company reassured investors saying it has the data and information to address the FDA’s questions.

For certain low-risk novel devices, the FDA’s De Novo pathway offers a swifter route to market. The FDA created the De Novo process in 1997 as an alternative pathway for companies bringing novel Class I and Class II devices to market via the pathway. The goal is to bring more transparency and predictability for manufacturers.

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“We have enjoyed a good relationship with the FDA in the development and review of our file,” Helius Medical CEO Philippe Deschamps said in a statement. “We believe we have the data and information to address the FDA’s questions and we look forward to submitting our response to enable the FDA to resume its review process as expeditiously as possible.”

Newtown, Pennsylvania-based Helius builds on noninvasive platform technologies that amplify the brain’s ability to heal itself. It is developing the PoNS device to help patients suffering brain injuries and chronic neurological diseases with movement, gait and balance disorders.

The company said it would continue to work towards “securing clearance” for the PoNS device.

“The PoNS device is a novel technology and our pursuit of a clearance is focused on providing a solution for patients suffering from chronic balance deficit due to mild-to-moderate traumatic brain injury, a condition that impacts more than two million people in the United States,” said Deschamps.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors